Medical Devices – Latest Updates

Update of MDCG 2021-5 Guidance on Standardisation of Medical Devices

3 July 2024

On 2 July 2024, the Medical Devices Coordination Group (MDCG (EN)) published the updated guidance document MDCG 2021-5 Rev.1 on various aspects of medical device standards in support of the requirements set out in the applicable EU legislation.

The main changes are summarised in tabular form on page 2 of the document MDCG 2021-5 Rev. 1, including i.a. the following points:

  • Removal of references to old directives and inclusion of references to updated regulations and directives,
  • Updating the “state of the art”,
  • Addition of references to EN ISO 15189 and ISO 14155:2011,
  • Addition of references to the MDR/IVDR standardisation proposal and its amendments,
  • Updates from IMDRF,
  • Information and clarification by CEN and CENELEC.

This document is essential for regulatory compliance and meeting health, performance and safety standards in the medical device industry.

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